CDC & NIH Biosafety Levels

The Centers for Disease Control (CDC) and the National Institutes of Health (NIH) have established four biosafety levels consisting of recommended laboratory practices, safety equipment, and facilities for various types of infectious agents. Each biosafety level accounts for the following:

Operations to be performed

Known and suspected routes of transmission

Laboratory function

The following sections discuss the Biosafety Levels:

Biosafety Level 1

Biosafety Level 1 precautions are appropriate for facilities that work with defined and characterized strains of viable organisms that do not cause disease in healthy adult humans (e.g., Bacillus subtilis and Naegleria gruberi). Level 1 precautions rely on standard microbial practices without special primary or secondary barriers. Biosafety Level 1 criteria are suitable for undergraduate and secondary education laboratories.

Biosafety Level 2

Biosafety Level 2 precautions are appropriate for facilities that work with a broad range of indigenous moderate-risk agents known to cause human disease (e.g., Hepatitis B virus, salmonellae, and Toxoplasma spp.). Level 2 precautions are necessary when working with human blood, body fluids, or tissues where the presence of an infectious agent is unknown. The primary hazards associated with level 2 agents are injection and ingestion. Most Texas State University research laboratories should comply with Biosafety Level 2 criteria.

Biosafety Level 3

Biosafety Level 3 precautions apply to facilities that work with indigenous or exotic agents with the potential for aerosol transmission and lethal infection (e.g., Mycobacterium tuberculosis). The primary hazards associated with level 3 agents are autoinoculation, ingestion, and inhalation. Level 3 precautions emphasize primary and secondary barriers. For primary protection, all laboratory manipulations should be performed in biological safety cabinet or other enclosed equipment. Secondary protection should include controlled access to the laboratory and a specialized ventilation system.

Biosafety Level 4

Biosafety Level 4 precautions are essential for facilities that work with dangerous and exotic agents with a high risk of causing life-threatening disease, the possibility of aerosol transmission, and no known vaccine or therapy (e.g., Marburg or Congo-Crimean viruses). Level 4 agents require complete isolation. Class III biological safety cabinets or full-body air-supplied positive-pressure safety suits are necessary when working with level 4 agents. In addition, isolated facilities, specialized ventilation, and waste management systems are required. There are no Biosafety Level 4 facilities at Texas State University.

Animal Biosafety

Four biosafety levels are also described for infectious disease work with laboratory animals. Animal Biosafety Levels 1, 2, 3, and 4 designate safety practices, equipment, and facilities.

Refer to the Laboratory Safety chapter for more information regarding the use of hazardous materials with laboratory research animals.